Positive Phase 1 Immune Responses in All Evaluable Ovarian and Breast Cancer Patients Advances Vaccine to Phase II Clinical Trials
January 12, 2015
Analysis of Phase I Trial indicates Safety and Positive Immune Response Data in 21 of 21 Patients Administered Folate Receptor Alpha Vaccine for Breast and Ovarian Cancers
January 12, 2015, Seattle WA, TapImmune Inc. (OTCQB: TPIV) is extremely pleased to report the completion of data analysis from all 21 evaluable patients treated in a Phase I clinical trial. In addition, TapImmune expects that the proceeds from the recently announced financing will provide immediate, short term and long term access to the capital required to exercise its exclusive option to license these very promising peptides from Ayer Special Situations Fund I, L.P. and to progress ongoing clinical programs into Phase II trials.
In the Phase I Trial conducted and Mayo Clinic, results indicate safety and positive immune response data in Folate Receptor Alpha Vaccine for ovarian and breast cancers. Eight women with HER2-negative breast cancer, thirteen with ovarian cancer and one with fallopian tube cancer were enrolled. The data shows that the vaccine containing antigens to the Folate Receptor Alpha protein was very well tolerated and safe. Increased specific T-cell immune responses against a set of 5 naturally processed Folate Receptor Alpha Class II antigenic epitopes were detected in 21 of 21 evaluable patients. This data confirms that the peptide vaccine stimulated a cellular immune response as mechanistically predicted. The combined safety (primary endpoint) and immune response data show that the trials have been successful and provide the catalyst for progression into Phase II clinical trials.
Folate receptor alpha is over-expressed in over 95% of ovarian cancers, for which the only treatment options are surgery and chemotherapy, leaving a very important and urgent clinical need for a new therapeutic. Time to recurrence is relatively short for this type of cancer and survival prognosis is extremely poor after recurrence.
Antigens to the folate receptor alpha are also over-expressed on triple-negative breast cancer cells, which comprise approximately 15-20% of all breast cancer patients. As there are approximately 40,000 new diagnoses a year and many hundreds of thousands of untreated patients at high risk of recurrence this represents an additional multi-billion dollar market potential. These indications and lack of available therapeutics make these drugs ideal candidates for fast track and Orphan Drug designation from the FDA and the company will be making those applications along with its Phase 2 FDA filings.
The company will provide an update on selection of Phase II indications over the next few weeks. TapImmune recently announced a collaboration with the Vaccine & Gene Therapy Institute of Florida (VGTI Florida) to advance the current programs into Phase II clinical trials in both ovarian and breast cancers (triple negative and Her2 positive). VGTI Florida is working with TapImmune on the design of clinical protocols, selection of clinical trial sites, recruitment of key opinion leaders as clinical advisors, and selection of external manufacturing and clinical resources.
Glynn Wilson, TapImmune’s CEO stated “We are excited by the progression of this Clinical Program into Phase II trials which is a significant step for the Company. In addition to the primary ovarian indication, this set of antigens and our unique approach fills a significant need for treatments for cancers, such as triple-negative breast, that are difficult to treat and for which targeted therapies are not available.
The Phase I trial has been carried out at the Mayo Clinic, Rochester, MN. The trial is fully accrued and as of August 26, 2014, all 22 patients had completed their vaccinations. Patients in the trial will be followed for an additional 18 months to evaluate secondary endpoints such as persistence of immunity and time to cancer recurrence. TapImmune has an Exclusive Option to License this antigen technology.
About TapImmune Inc.
TapImmune Inc. is an immunotherapy company specializing in the development of innovative vaccine technologies for the treatment of cancer and infectious disease. The Company’s vaccine compositions, peptide or nucleic acid-based, comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patient’s killer T-cells and helper T-cells and to restore or further augment antigen presentation by the modulation of TAP (Transporter associated with Antigen Processing). The Company believes that its vaccine compositions may be used as stand-alone medications or in combination with current treatment modalities. Please visit the Company’s website at markertherapeutics.com for details.
Forward-Looking Statement Disclaimer: This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements”. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update the forward-looking statements
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